Chronic pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage, with a high prevalence in Spain (25.9%) and an average duration of 6.83 years, highlighting its significant health and social impact. Among its manifestations, chronic low back pain (CLBP) is the most common, affecting 58.1% of individuals with chronic pain, while fibromyalgia (FM) accounts for 10.4%. In both cases, a relevant proportion of patients do not present a clear organic cause, which complicates diagnosis and treatment and reflects the complexity of nonspecific chronic pain. CLBP is associated with a high functional and occupational impact, being one of the main causes of temporary disability. FM, on the other hand, is characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbances, and emotional symptoms, constituting a condition with systemic involvement. Both conditions can occur throughout the lifespan, with variations in prevalence depending on age, sex, social class, and the presence of comorbidities. Aging introduces relevant differences in pain experience and treatment response. At the physiological level, changes occur in the musculoskeletal system, such as the progressive loss of muscle mass (especially type II fibers) and decreased bone mineral density, which increases the risk of sarcopenia and frailty. In contrast, young adults show greater anabolic capacity, better hypertrophic response, and higher neuromuscular efficiency, favoring faster adaptations to exercise. These differences justify the need to consider age as a key factor in the therapeutic approach. In addition to structural changes, central sensitization plays a fundamental role in the chronification of pain. This process involves sustained hyperexcitability of the central nervous system, with a reduced pain threshold and altered inhibitory mechanisms, contributing to the persistence of pain even in the absence of significant tissue damage. Therapeutic exercise (TE) is one of the main non-pharmacological interventions for chronic pain and has demonstrated effectiveness in reducing pain and improving functionality. However, its long-term effects are limited, largely due to adherence issues related to pain, as well as psychological, social, and educational factors. Educational level influences both the understanding of the intervention and adherence, generally being higher in young adults, which may affect treatment outcomes. In this context, Pain Neuroscience Education (PNE) has emerged as a complementary strategy aimed at improving understanding of pain mechanisms and promoting adaptive behavioral changes. The combination of PNE and TE has shown positive effects in patients with CLBP and FM, especially in variables related to pain and psychosocial factors. However, there is a lack of evidence regarding the impact of this combination on objective functional parameters, such as spinal movement during functional activities. Therefore, it is necessary to investigate the effectiveness of the combined intervention of PNE and TE not only on pain but also on biomechanical variables such as range, velocity, and quality of movement, using precise measurement instruments.
This study aims to evaluate the effectiveness of Pain Neuroscience Education (PNE) combined with Therapeutic Exercise (TE) in individuals with chronic low back pain (CLBP) and fibromyalgia (FM). Chronic pain conditions are frequently associated with maladaptive pain beliefs, pain catastrophizing, central sensitization, and functional limitations. PNE has been proposed as an educational approach to improve patients' understanding of pain mechanisms and promote adaptive coping strategies, potentially enhancing the effects of exercise-based interventions. The study is designed as a randomized controlled clinical trial including participants with either CLBP or FM. Participants will be stratified according to age (\<65 years and ≥65 years) and clinical condition (CLBP or FM) and then randomly assigned to one of two intervention groups: (1) PNE combined with TE, or (2) placebo education combined with the same TE program. The intervention period will last eight weeks. All participants will perform a standardized therapeutic exercise program focused on physical function and movement. Participants allocated to the experimental group will additionally receive PNE sessions addressing contemporary pain neuroscience concepts, including pain mechanisms, central sensitization, the influence of psychosocial factors, fear of movement, and self-management strategies. Participants in the control group will receive placebo educational sessions focused on anatomy and biomechanics, matched for duration and attention. Assessments will be conducted at baseline, immediately after the intervention, and during follow-up periods at 4, 12, and 24 weeks after treatment completion. The study will examine changes in pain-related, psychological, sensory, and functional outcomes over time and compare responses between clinical conditions and age groups. The results of this study may contribute to understanding the added value of PNE when combined with therapeutic exercise and whether age and clinical diagnosis influence treatment response in individuals with chronic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
For the experimental group, the intervention consists of an 8-week therapeutic exercise program combined with education on the neuroscience of pain, comprising 3 exercise sessions and 1 educational session per week.
For the control group, the intervention consists of a therapeutic exercise program combined with placebo education, which introduces basic concepts of anatomy and biomechanics. The intervention lasts 8 weeks, with 3 exercise sessions and 1 education session per week.
Facultat de Fisioteràpia
Valencia, Valencia, Spain
Level of physical activity
Using the International Physical Activity Questionnaire (IPAQ). Scores are expressed in MET-minutes/week. Higher scores indicate higher levels of physical activity and a better outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Central level of awareness
Using the Central Sensitization Inventory (CSI). Total score ranges from 0 to 100. Higher scores indicate greater symptoms related to central sensitization and a worse outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Pain on movement
Pain using the Visual Analogue Scale (VAS): Scores range from 0 to 10, with higher scores indicating greater pain intensity and a worse outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Level of catastrophizing
Level of catastrophizing using the Pain Catastrophizing Scale (PCS). Total score ranges from 0 to 52. Higher scores indicate greater pain catastrophizing and a worse outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - Lumbar movements
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The tests measured using the motion capture system will be: lumbar flexion-extension, rotations, and lateral bending.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - The 5 Time Sit to Stand Test
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be the 5-Time Sit-to-Stand Test. he outcome is the time required to complete five consecutive sit-to-stand repetitions, measured in seconds. Scores range from 0 seconds to no theoretical maximum. Higher scores indicate poorer lower-limb functional performance and a worse outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Functionality - Lifting a 5 kg ball off the floor
Using a motion capture system. Each movement is performed 5 times (the middle 3 repetitions will be analyzed). In all cases, pain will be assessed using a visual analog scale ranging from 0 to 10. Thirty-six markers will be placed throughout the body, except on the hands. The test measured using the motion capture system will be lifting a 5 kg ball from the floor in a free-standing position, in a deadlift and in a squat.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Degree of disability
Using the Oswestry Disability Index (ODI): Scores range from 0 to 100%, with higher scores indicating greater disability and a worse outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Conditioned Sensitivity Test
Test to assess the condition of the nervous system. The test stimulus is applied using an algometer, and the pressure pain threshold is assessed on the tibialis anterior muscle (5 cm distal to the tibial tuberosity). The patient verbally reports the point at which pressure becomes painful (the average of three consecutive measurements is calculated). Next, a conditioning stimulus is applied using a blood pressure cuff at a constant pressure of 240 mmHg for 120 seconds. Finally, the pressure pain threshold in the tibialis anterior is assessed.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Biering-Sörensen Test
This is a functional test of the lumbar spine used to measure the isometric strength and endurance of the trunk extensor muscles, particularly in the lumbar spine. This test is measured using surface electromyography (EMG), and the electrodes-which are 20 mm in size-should be placed on the iliocostalis muscle 3-4 cm lateral to the midline and at the level of L2-L4.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anthropometric data - Weigth
Weight will be measured using a bioimpedance scale and will be reported in kilograms.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Demographic data - Age
Age. Age will be expressed in years.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anthropometric data - Body Mass Index (BMI)
Body Mass Index. BMI will be measured using a bioimpedance scale and will be expressed as a percentage and in kg/m²
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Demographic data - Gender
Gender (male or female)
Time frame: In the initial valuation.
Sensitivity
Using the Semmes-Weinstein monofilament test for tactile sensitivity and the pinprick test for pain sensitivity by dermatome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Anxiety and depression
Using the Hospital Anxiety and Depression Scale (HADS). Total score ranges from 0 to 42. Higher scores indicate greater anxiety and depression symptoms and a worse outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
Kinesiophobia
Using the Fear-Avoidance Beliefs Questionnaire (FABQ). Total score ranges from 0 to 96. Higher scores indicate stronger fear-avoidance beliefs and a worse outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.
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Fibromyalgia Index
Using the Fibromyalgia Impact Questionnaire (FIQ).Total score ranges from 0 to 100. Higher scores indicate greater impact of fibromyalgia and a worse outcome.
Time frame: Before the procedure, after the procedure, one month later, three months later, and six months later the procedure.